18 Aug
|
Global Calcium
|
Hosur
18 Aug
Global Calcium
Hosur
Job Summary
Global Calcium Pvt. Ltd., a leading pharmaceutical company, is seeking a Quality Control Analyst with 3–5 years of experience in API (Oncology). The ideal candidate will be responsible for analytical testing, documentation, and ensuring compliance with cGMP and regulatory standards. This position is critical in maintaining quality across all stages of production.
Key Responsibilities
Perform analysis of raw materials, intermediates, finished products, in-process materials, packing materials, and stability samples
Operate and maintain analytical instruments:
HPLC (Shimadzu, Agilent, Empower, Chromeleon)
GC, IR, UV, Moisture Balance, Karl Fischer (KF), Potentiometric Titration
Conduct analytical investigations including:
System Suitability Tests
Laboratory Investigations
OOS (Out of Specification), OOT (Out of Trend) analysis
Root Cause Analysis and implementation of CAPA
Ensure adherence to GMP, GLP, and applicable regulatory standards (FDA, WHO, ICH)
Maintain accurate documentation and data integrity in compliance with audit and inspection requirements
Collaborate with QA, ADL, R&D;, and Production teams for process improvements
Identify documentation gaps and suggest improvements to ensure compliance and efficiency
Support internal and external audits through proactive documentation and team coordination
Key Skills & Competencies
Solid analytical and documentation skills
In-depth knowledge of cGMP/GLP and regulatory guidelines
Proficiency in using analytical software (LabSolutions, Empower, Chromeleon)
Detail-oriented with a passion for quality and data accuracy
Excellent problem-solving and root cause analysis skills
Team player with valuable communication and interpersonal abilities
Experience: 3 to 5 years in Quality Control
Educational Qualification : MSc / BSc in Chemistry / Analytical Chemistry
Industry: Pharma Bulk Drug /API/API oncology
📌 Officer/ Executive Hosur
🏢 Global Calcium
📍 Hosur